Data / Medical devices / Italy / Leone SPA

Leone SPA: FDA-registered device maker in Sesto Fiorentino Firenze, Italy, 3 510(k) clearances

Name: Leone SPA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Leone SPA is registered with the FDA (registration 3001561923) in Sesto Fiorentino Firenze, Italy. It lists 25 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 7, 2009. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3001561923
Address: 50, Via P. A Quaracchi, Sesto Fiorentino Firenze, Italy, I-50019
Owner or operator: LEONE SPA (9051868)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: June 27, 2002
Registered through: 2026
Brand names listed: AQUA/Ceramic brackets, BIOSTELL, BURS, Band driver and adapter, Bracket positioning gauges, CALIBRA, DRILLS, Dental wax and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Aligner, Bracket, Orthodontic	ECQ	1	Manufacturer	accessdata.fda.gov
Alloy, Other Noble Metal	EJS	2	Manufacturer, Specification developer	accessdata.fda.gov
Band, Elastic, Orthodontic	ECI	1	Manufacturer, Specification developer	accessdata.fda.gov
Band, Preformed, Orthodontic	ECM	1	Manufacturer	accessdata.fda.gov
Bracket, Ceramic, Orthodontic	NJM	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Clamp, Wire, Orthodontic	ECN	1	Manufacturer	accessdata.fda.gov
Clasp, Preformed	EHP	1	Manufacturer, Specification developer	accessdata.fda.gov
Headgear, Extraoral, Orthodontic	DZB	2	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Orthodontic	OAT	2	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Instrument, Cutting, Operative	EKD	1	Manufacturer	accessdata.fda.gov
Instrument, Ligature Tucking, Orthodontic	ECP	1	Manufacturer	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Manufacturer, Specification developer	accessdata.fda.gov
Pliers, Operative	EJY	1	Manufacturer	accessdata.fda.gov
Pusher, Band, Orthodontic	ECS	1	Manufacturer	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Manufacturer	accessdata.fda.gov
Spring, Orthodontic	ECO	1	Manufacturer, Specification developer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov
Tube, Orthodontic	DZD	1	Manufacturer	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Manufacturer, Specification developer	accessdata.fda.gov
Wire, Orthodontic	DZC	1	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 7, 2009	K091702	CDB FLIP-SIDE-CLIP BRACKET	NJM	Substantially Equivalent	Cdb Corporation	accessdata.fda.gov
February 22, 2008	K071490	LEONE ORTHODONTIC MINI IMPLANT	OAT	Substantially Equivalent	Leone S.P.A.	accessdata.fda.gov
February 27, 2006	K050586	LEONE IMPLANT SYSTEM	DZE	Substantially Equivalent	Leone S.P.A.	accessdata.fda.gov

Compare with other makers

Updated August 7, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.